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Complete Response Letters: Firms See Value In Public Release, Don't Expect It Will Happen

Executive Summary

One industry CEO says it would on net be beneficial even though some companies would suffer if they were made public.

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Agency want to identify a 'manageable' subset of letters for release in which drug approval was denied for reasons, such as safety concerns, that can help inform clinical practice and impact public health, Commissioner Gottlieb says, adding: 'I'm not sure that that's doable. I'm inclined to think that it might be.'

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